Surgical Mesh: The Ten Year Window

The Ten Year Window

I have spent many years in the health care industry. The outcome of the observations I have made tells me that most often it takes about 10 years for facts to catch up with drug, treatments, and device approvals.

Approvals in this arena come from the Food and Drug Administration (FDA). Commonly, because of the faster fast track system instituted now for a couple of decades, money buys the ticket to the train. When first instituted Fast Track cost a manufacturer about $330,000; now it is at least double.

This doesn’t end up doing too much for safety because, if you follow the news, you too frequently hear about a drug recall, an ineffective treatment, or medical device failures along with product liability law suits.

Surgical mesh offers no different scenario.

The FDA orders Johnson & Johnson, C.R. Bard and 31 other companies to take another look at complication rates associated with their transvaginal mesh implants.

Retropubic urethral suspension was first used in 1910. Since that time over 100 different surgical techniques for the treatment of genuine stress urinary incontinence (GSUI) have been described.

Procedures done through the abdomen have been referred to as "bladder lifts". These include procedures known as the Burch repair and Marshall-Marchetti (1949) procedure. Although these are very "old" surgical procedures, the results have proven durable over time.

Some surgeons believe that the sling surgery should be used only in certain special cases because of its higher rate of complications and because they have found the older surgery techniques to be effective.

Pubovaginal Sling Procedures 

In instances where mesh may be contraindicated the procedures can be done with natural products such as bovine, or cadaver grafts.

Your physician should discuss all options with you for your situation to help you to decide which procedure is the correct one for you.

In the early 1990s, at the time use of surgical mesh began becoming popular there were no long term studies available on the differing types of products, and few long term studies of the surgical techniques.

Vaginal mesh repair has become popular, because of access to the areas involved in surgery, ease of application using the manufacturers' needles, variable mesh sizes that can be cut to size during surgery, laparotomy is not required, the option of achieving permanent tissue replacement after failure of tissue reconstruction, and experience with similar materials.

According to Dr. Saralyn Mark, a spokesperson for COOK in the capacity of Senior Scientific Policy Advisor, surgical mesh has been used for over a decade. COOK has provided biologically-derived grafts that are not cross-linked, including grafts for pelvic organ prolapse, for about 13 years. Dr. Mark’s statement was part of her presentation in September 2011 at the FDA conference covering the problems with this product.

There are several types of mesh or similar products and they are most often used in surgery involving hernia, uterine prolapse, bladder prolapse, rectocele, cystocele, and other applications.

Synthetic mesh is found in absorbable and non-absorbable forms. Biologically derived graft material is offered in cross-linked and non-crosslinked forms.

The type of material selected and the outcome of surgery is, according to Marks, best determined by “(1) assuring that the patient is a suitable candidate, (2) performing the procedure correctly, and (3) choosing the appropriate product”.

Based on the three criteria, Marks went on to state that she reviewed numerous articles where the studies referenced one of the four types of material for implant.

COOK’s findings show that most non-absorbable synthetic mesh is made of Type I polypropylene. Outcomes for this type material suggest that there is a strong bond with mesh and surrounding tissue encapsulation. In some cases the long term tissue response is more like a foreign body reactions that may include granulation tissue, limited neovascularization, eventual fibrosis, and encapsulation.

Foreign body reactions are similar to transplant surgeries where anti-rejection drugs are commonly prescribed in an effort to reduce risk of rejection.

Absorbable synthetic mesh can rapidly degrade and does not provide long term tissue support. For this reason this type of product is rarely used.

Cross-linked biologic grafts are made with chemical agents to bond or “cross-link” collagen fibers together in an effort to reduce degradation. The material seems not to support normal movement of body cells into the graft is significantly. Because of this inflammation occurs and over time leads to a foreign body reaction and encapsulation. The tissue response of chemically cross-linked graft material has been found to be very similar to the synthetic products.

Non-crosslinked biologic grafts are minimally processed to remove cells and leave no cross-linked collagen.

They offer both mechanical strength and a platform to promote “cellular infiltration, proliferation, and remodeling of the patient’s tissue”. Long term outcome with this type product aids repair and reinforcement as the graft is replaced by connective tissue and normal blood supply.

Review of 15 years of reports using different types of graft material evaluated these studies for incidence of “(1) erosion, (2) pain including dyspareunia, (3) graft-related infection, (4) persistence or recurrence of prolapse based on objective measures (such as the POP-Q score), and (5) symptomatic recurrence.”

Of these five parameters the final evaluation specifically looked at three objective measures for each type of material: (1) erosion, (2) infection, and (3) objective measurement of recurrence. Pain and other symptomatic complaints were excluded.

Overall findings with non-absorbable synthetic mesh products had a 10% erosion rate, while crosslinked biologics had 6.2% rate. Repairs with non-crosslinked biologic grafts had the lowest erosion rate at 1.2%.

Infection rates associated with material types were approximately 4.0%.

Of course and of great concern to patients are pain and other complaints, including but not limited to forced lifestyle change and quality of life concerns.

There is great consideration given to the need for follow-up sonography to evaluate the anterior and posterior mesh positions after prolapse surgery. Reported frequently is a considerable discrepancy between the implanted mesh size and its length measured after six weeks by postoperative ultrasound.

In consideration of economic cost, the recently reported direct cost of pelvic organ prolapse surgeries were between $1012 million and $1251 million dollars. Of this $494 million (49%) covered costs for vaginal hysterectomy; $279 million (28%) were costs for both cystocele and rectocele repair; and $135 million dollars (13%) were allocated for abdominal hysterectomy.

Physician services accounted for 29% ($298 million) of total costs, and hospitalization accounted for 71% ($714 million). Twenty-one percent of all reported pelvic organ prolapse operations included urinary incontinence procedures ($218 million). If all of the reported surgeries were reimbursed by non-Medicare sources, the annual estimated cost would increase by 52% to $1543 million.

Procedures using surgical mesh are permanent. There may be benefit in first understanding long term complications as these may include mesh erosion into the vagina, bladder or rectum; painful intercourse; infection or bleeding.

The FDA has received thousands of complaints about surgical mesh. Examples follow of manufacturer and complaints filed as of 2009 -

Manufacturer Product names and Number of MAUDE* reports

American Medical Systems SPARC 65

Bard Pelvicol, Pelvisoft 64, 1

Boston Scientific Scimed Prefyx PPS, Obtryx Curved Single, Obtryx Mesh Sling, Advantage Sling System, Prefyx System Mid U, Mesh Sling System23, 1, 62, 29, 23, 78

Caldera T-Sling 2

Ethicon Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor, Prolene Polypropylene Mesh 123, 72

Gynecare Secur, Tension Free Vaginal Tape 1, 4

Johnson & Johnson – Switzerland K974098 495

Mentor ObTape (K031767) 236

Sofradim Uretex TO, Avaulta Biosynthetic, Uretex Pubovaginal Sling/support kit, Bard Posterior Biosynthetic Support System, Pelvetex Polypropylene Mesh 64, 0, 27, 3, 0

*MAUDE (Manufacturer and User Facility Device Experience) data represents reports of adverse events involving medical devices received by the FDA.

Cases involving Kugel Mesh Hernia Patches involving hernia repair are also on the increase. Davol, Inc., a division of the C. R. Bard, Inc., in December 2005 issued a recall following reports that the patch memory recoil ring may not withstand stresses associated with specific surgical placement techniques. The recall extended into 2006 and a law suit was filed against this product in December 2006.

Expanded recalls into 2007 were related to memory recoil ring breaks that had caused bowel perforation, bowel obstruction, internal pain, internal fistulas, migration through the abdominal wall, and additional surgery for repair or removal of mesh, blood clots, and death caused by septic shock. A case of acute heart attack secondary to surgery for bowel fistula repair was caused by perforation from the broken memory recoil ring.

Infertility has been reported secondary to a fibrotic reaction to mesh used in surgery for repair of inguinal hernia.

Some studies report that there can be a systemic allergic reaction to polypropylene mesh used in surgical treatment. These studies found too that Polytetrafluoroethylene (PTFE - fluoride) coated mesh, DuPont’s synthetic fluoropolymer of tetrafluoroethylene, may cause a greater risk.

Many researchers determined that skin patch tests should be conducted on patients in a timely manner before undergoing any surgery using polypropylene materials.

Davol and Bard were later involved in an FDA criminal investigation related to the sale of counterfeit surgical mesh kits containing flat sheets of polypropylene.

Between 2002 and 2006 Davol sold approximately 32,000 kits worldwide. In 2005 mesh kit sales generated $11 million for this firm.

In September 2011 the FDA called for the Obstetrics & Gynecology Devices Advisory Committee to discuss the issues related to the use of surgical mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The panel discussed the use of surgical mesh and its risks and benefits based on the literature and adverse reporting data (MAUDE).

Comments were taken about proposed FDA premarket and post market regulatory strategies for surgical mesh use in POP and SUI, and reclassification from Class II into Class III.

The goal of the panel is to assist FDA in determining whether there is need for additional clinical studies (premarket and/or post market) on surgical mesh use, based on data from the published literature and the MAUDE database. 

Perhaps as we move in to the future more careful consideration will be given to evaluation based on other than journal articles and adverse reporting data.

This article is part of a consumer health education series written by Gayle Eversole, DHom, PhD, MH, NP, ND, of Creating Health Institute, in collaboration with Chaffin Luhana LLP

The views expressed in this article are solely those of the author, Gayle Eversole.

Transvaginal Mesh 1

http://naturalhealthnews.blogspot.com/2011/10/fda-slow-to-take-action-on-vaginal-mesh.html


http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html


http://naturalhealthnews.blogspot.com/p/womens-health-transvaginal-mesh.html


http://leaflady.org/mesh2.htm

A Most Sensible Resolution for 2012

Water!


Yes, you've heard this cry many times I am sure.  But even in today's world it is extremely important to your health.  Its also not the truth, as so many in mainstream medicine tell you, that those 8 glasses a days aren't necessary. 


Well, I certainly agree that the 8 glasses are needed, and I have my surgeon father to thank for that.  When he was in med school in the 1920s this was the rule.


The "Cool Morning Draught" was also a very popular and health promoting traditional naturopathic therapy, and my mother always started her day this way. One of her favorite songs was "Cool Water" as sung by the Sons of the Pioneers.  She was lucky enough to have come from the place that supplies artesian wells drinking water to New Orleans.


Seems too that forward thinking and health supporting doctors agree - one who I think offers trustworthy and practical advice about all aspects of healthy living.

DEHYDRATION CHECK:  If your tongue feels at all raspy 

or like sandpaper then you too aren't getting enough water.

from Dr. John Briffa -

I sat down two days ago with some ambition to write a blog post (or two). In the end I did not write a word. Why? As I explained to my girlfriend, ‘my brain wasn’t working’. Try as I might, I found the whole idea of writing anything cogent too much. I did a quick scan of things that might have caused this state. I was not short on sleep. Neither had I eaten any wheat (I’ve found from experience this tends to turn my brain off).
Then I wondered if I might be dehydrated. It was about 4.00 in the afternoon, and I could only remember passing water twice all day – not a good sign. Plus, there was no doubt in my mind that I had drunk only a small proportion of the water I would normally consume when, say, in my own home. I stepped up my water intake and felt quite quickly revived. It might have been a placebo response, but maybe not.
This morning I decided to see if there was any recent evidence on the impact of dehydration on mental functioning, and did indeed come across a relevant study [1]. In this research, 25 women were subjected to a variety of assessments of mood, mental functioning and wellbeing in a normally hydrated state, as well as a dehydrated state. On one occasion, dehydration was induced with intermittent exercise but not heat. On another occasion, dehydration was induced not just with exercise, but by administration of the diuretic drug frusemide (furosemide).
Overall, dehydration with or without frusemide led to an average of 1.36 per cent of body mass. Just to put this into perspective, for someone weighing 70 kg, this would equate to about 1 kg (or 1 litre) of dehydration. In other words, this extent of dehydration would be described as ‘mild’.
At this level of dehydration, basic cognitive (brain) function was not significantly affected. But other functions were, including the amount of perceived effort used by women to complete a task. My experience yesterday meant that I could totally relate to this.
In addition, the concentration and mood of the women were also adversely affected. The women were more fatigued too, and were more prone to headaches. All this, remember, was the result of relatively mild dehydration.
None of this actually proves my inertia yesterday was caused by something as simple and rectifiable as dehydration, but it is at least consistent with it. I’d say as far a New Year resolutions go, many of us could do a lot worse than just to ensure we’re decently hydrated. How much should we drink? I suggest enough to ensure our urine stays pale yellow in colour throughout the day.
References: 1. Armstrong LE, et al. Mild Dehydration Affects Mood in Healthy Young Women J Nutr January 1, 2012 jn.111.142000

Advanced Care Chiropractic offers this short report -

Just because it is winter and it is cold and rainy, doesn’t mean you can’t get dehydrated!  During these months we are inside more, with heaters going, and we don’t have that natural thirst mechanism.  So most of the patients I see ARE dehydrated.

Water is your body’s principal chemical component, comprising 60-70% of your weight. Every system in your body depends on water.  Even mild dehydration can sap your energy and make you tired. 

Lack of water increases fibrosis and cross-linking in collagen, resulting in advanced wrinkling,  stiff and easily injured joints, and degeneration of joints and discs.  

It also makes chiropractic adjustments more difficult, more painful, and less effective. 

Every day you lose water through your breath, perspiration, urine and bowel movements. For your body to function properly, you must replenish its water supply by consuming beverages and foods that contain water.

1) How Much?  The US National Research Council recommends 1 mL of water for every Calorie you eat.  So if you eat 2000 Calories you should be drinking 2000 mL (2 liters or 2.1 quarts).  My guideline is ½ oz of water for every pound of weight.  So for a 150 lb man or woman, you need 75 oz of water (over 2 quarts).

You may need to modify your total fluid intake depending on how active you are, the environment or weather you are in, your health status, and if you’re pregnant or breast-feeding.

• Exercise. The more you exercise, the more fluid you’ll need to keep your body hydrated. An extra 1 or 2 cups of water should suffice for short bouts of exercise, but intense exercise lasting more than an hour (for example, running a marathon) requires additional fluid. During long bouts of intense exercise, it’s best to use a sports drink that contains sodium and electrolytes to help replace sodium lost in sweat. Fluid also should be replaced after exercise.
• Environment. Hot or humid weather can make you sweat and requires additional intake of fluid. Heated indoor air also can cause your skin to lose moisture during wintertime. Further, high altitudes may trigger increased urination and more rapid breathing, which use up more of your fluid reserves.
• Illnesses or health conditions. Fever, vomiting and diarrhea cause your body to lose additional fluids. In these cases you should drink more water and may even need oral rehydration solutions, such as Gatorade.  Certain conditions such as heart failure and some types of kidney, liver and adrenal diseases may impair excretion of water and even require that you limit your fluid intake.
• Pregnancy or breast-feeding. Women who are expecting or breast-feeding need additional fluids to stay hydrated. Large amounts of fluid are lost especially when nursing.  It is recommended that pregnant women drink 2.4 liters (about 10 cups) of fluids daily and women who breast-feed 3.0 liters (about 12.5 cups).

2) Don’t wait until you are thirsty!   It’s generally not a good idea to use thirst alone as a guide for when to drink. By the time you becomes thirsty, it is possible to be already dehydrated.  Be aware that as you get older your body is less able to sense dehydration and send your brain signals of thirst. 

3) Avoid drinking at night! Don’t try to catch up for not drinking during the day by drinking too much in the evening.  Avoid drinking 2 hours before bedtime.  Unless you LIKE waking up in the middle of the night!

4) Water filters, spring water, bottled waterIf you drink water from a bottle, thoroughly clean or replace the bottle often. Refill only bottles that are designed for reuse.  In general spring water from a tested source is best, then filtered water.  Don’t drink distilled water. 

5) Drink Warm or Room Temperature Water  You wouldn’t put ice water in a baby’s water bottle, a pet dish or a house plant would you?  Then avoid it for yourself too.  Traditional Chinese Medicine declares that cold drinks “shock” the body and blocks the normal flow of energy. 

6) Can You Drink Too Much?  Though rare, it is possible to drink too much water. When your kidneys are unable to excrete the excess water, the electrolyte content of the blood is diluted, resulting in a condition called hyponatremia.   Endurance athletes such as marathon runners who drink large amounts of water are at higher risk of hyponatremia.  In general, though, drinking too much water is rare in healthy adults who consume an average American diet. 

Water


Selections from Natural Health News

Natural Health News: Weight Loss Promise for a new year

Dec 26, 2007

Lose weight with water. Water is essential for everybody - it is also the key to losing weight. If you haven't been drinking enough water, your body has developed a pattern of storing water. This water retention equals extra ...

Natural Health News: Words on Water

Apr 03, 2008

The hot topic in current news seems to be water, and how much you don't need. This topic has made the news several times in the past few years, sometimes to the chagrin of health advocates who believe water is life giving. 

Natural Health News: Less Calories, More Water

Aug 24, 2010

Drinking water with meals has always been a point of discussion in natural health care. We have learned, and educate others about water and how important it is for health. We also always have suggested to drink water ...

A Great Book for Women's Health

You'll find many of my natural health suggestions included in 

The Woman's Book of Healing Herbs.